Dynamic tension brace or support

ABSTRACT

The invention comprises an elastomeric athletic or orthopedic brace, support for a joint complex and is a network of interlinking elastomeric bands that extend radially from a hub member to support a joint in tension but provide for controlled hinging about an axis defined through the hub member. In particular, the brace is provided for an ankle.

FIELD OF THE INVENTION

The invention relates to generally to an elastomeric athletic ororthopedic brace or support that mimics the manner in which theligaments provide support for a joint complex, and in particular, havingan external, adjustable network of elastomeric interlinking supportbands that radiate outwardly from a hub to act in tension for additionaljoint stabilization.

BACKGROUND OF THE INVENTION

The invention generally provides an athletic or orthopedic brace orsupport, which in a first embodiment, involves an elastomeric sleevehaving fenestrations meaning in this instance, areas of reduced support,which may be openings or which may include an area of a softer or moreyielding material characterized by a lower durometer material. The bracesurrounds and supports one or more joints so as to provide an externalanatomically configured framework which mimics or augments the effectsof the ligaments. In a further embodiment, the brace includes a portionthat can be opened and closed such as with adjustable strap members thatalso can be used to achieve tensioning as needed.

In a still further embodiment, the brace includes opposing hubs, such ason the medial and lateral side of the ankle joint which together definean axis about which a first member of the brace pivots relate to asecond member of the brace. For most uses, the top member can be aproximal member while the bottom member can be a distal member, and foran exemplary embodiment for use on an ankle, the top member is a legmember and the bottom member is a foot member and the brace includes amedial hub (i.e. a support which surrounds at least 180 degrees, andpreferably at least 270 degrees, and advantageously, 360 degrees of themedial malleoli) and similarly, a lateral hub. Together these hubmembers include an opening or weakened area in the middle which sits onthe ankle bones (i.e. malleoli) to define an axis about which the anklehinges and which the brace permits while still inhibiting movement inother planes, such as torsion or twisting. The network also includes aplurality of strut members comprising a first set of struts on themedial side of the ankle brace and a second set of struts on the lateralside of the ankle. The medial set of struts radiate outwardly from themedial hub and are linked to the periphery of the brace on the medialside and the lateral set of struts radial outwardly from the lateral huband are linked to the periphery of the brace on the lateral side of thebrace. The periphery comprises a cycle of reinforced portions whichinclude a band which surrounds the proximal portion of the brace and onewhich surrounds the distal portion of the brace, and wherein theproximal band or anchor is linked to the distal band or anchor by ananterior band on the top of the brace and a posterior band or bands onthe bottom of the brace. Advantageously the anterior band is offset fromthe front of the ankle and the posterior or planar band comprises aseries of bands on the soul of the brace. The anterior band can includemeans for fastening or adjustment, including for example, the hook orloop of a Velcro™ fastening assembly. The mating portion of thefastening means can advantageously be held on straps that extend fromthe rear of the brace, such as a medial strap and a lateral strap whichencircle the ankle and which encircle or spiral about the ankle so as todirect the tension of the brace around the ankle, and around the brace.

The spaced hubs, pairs of radial struts and the peripheral linkedsupport act to limit the lateral motion (i.e., side to side or torque ortwisting) while allowing the hinging of the brace much in the way thatthe spokes of a wire spoked wheel or the cables of a tension bridge actto support the main body in tension while the main body member acceptsand transmits compressive forces. Thus the brace encourages rebound orrecoil in the permitted direction while inhibiting motion that is morelikely to have the potential to harm the joint. The medial or inside setof struts thus includes one or two upwardly extending strut members thatjoin at the bottom to the medial hub and on the top to a proximal bandof the brace network and one or two diagonally extending strut membersthat extend from the medial hub to a distal band of the brace network.The inside set of struts can also include a posterior set of struts thatjoin to a rear band that encircles the heel of the user, oralternatively, the hub can connect directly to the rear band. Since thebrace preferably is open at the heel and to the rear for entry, itincludes a rear band that circles the heel cut-out and extends alongeach edge of the rear of the brace and joins to the proximal band, evenby extending in an intermediate strap for closure and adjustment

On one side, preferable the lateral side, the rear band extends into astrap which laps over the medial side of the brace and fastens, such asabout the top of the brace. The outside or lateral set of strutslikewise include a corresponding network of radially extending strutmembers, such as one or two upwardly extending members that connect thelateral hub to the proximal edge and one or two diagonally extendingstrut members that connect the lateral hub to the front edge of the footmember and a downward strut that connects the lateral hub to the bottomof the heel band and a rearward extending strut that connects the hub tothe rear portion of the rear band which extends into a strap that spiralfrom inferior to superior and across the front of the ankle to close thebrace to a desired tightness. This configuration of the brace allows arear entry brace which closes around the front in such a way that theclosure means serve primarily for sizing and tightening, and are notsubject to the direct forces that tend to cause closure means to wearout, for example, when the hook and loop of Velcro is tensioned alongthe direction of fastening. Preferably, the brace further includes asleeve or web of underlying elastomeric material which underlies thenetwork of supports so as to distribute the forces of the network overthe users skin and to provide a comfortable layer which may includetexturing, such as nibs, notches or perforations so as to increase theproprioceptive aspects of the brace and also to permit the brace to“breath” or to allow sweat to evaporate from under the brace.

The brace can be used prophylactically (for example, allowing sufficientrange of motion to allow the brace to be worn during athletic activitieswithout hindering the athlete, but which acts to support the joint orjoint complex and to inhibit potentially harmful motion) or the bracecan be used therapeutically (for example, in the aid of healing of ajoint or joint complex which has suffered some previous injury). Thebrace has application in all of the joints, including the shoulder,elbow, wrist, hand, thumb, foot, knee, hip and back and the concepts ofthe present invention can be applied to each of these joint complexes,but is illustrated specifically with respect to an ankle brace. Thebrace further comprises embodiments in which 1) the brace is adjustableand includes self-closure mechanisms such as a strap or web of linkingmembers that also act to add support as well as provide for size, fit,or tensioning adjustment; in which 2) the brace includes movementmonitoring means molded into or inserted in pockets in the brace or thepockets are provided with additional support or rigid stiffeningmembers; in which 3) the brace includes integral use specific functionalstiffening members or protection, such as shin or forearm guards; and inwhich 4) the brace includes optional additional elastic motion relatedsupport members which are directed to specific physiological orkinesthetic purposes.

Joint sprains are a common occurrence and in particular, ankle sprainsaccount for an estimated 2 million injuries per year in the UnitedStates, and occur in nearly all types of sporting events, making themthe most common sports-related injury. A practical method of decreasingthe number and severity of these injuries would clearly be of greatbenefit since ankle sprains result in a risk of further, and even moresevere injury and lasting ankle problems, as well as significant timeaway from games and practices. To this end, many people use prophylacticbracing or ankle taping as a means to decrease the risk of injury,including people who have suffered in the past from a sprained ankle, orin instances where there may be an increased tendency to injury, such asfor joints that are subjected to rigorous use or use in uneven terrain.However, while taping is commonly viewed as effective, it is extremelylabor intensive, is good for a single use, and requires an educatedapplication all of which cause it to be very expensive. Thus, thepresent invention provides an alternative solution, which is easy to puton, is durable, and which is a relatively inexpensive way to achieve asimilar or better result.

It is helpful to understand ankle anatomy in order to understand anklesprains. The ankle (talar) joint has three bones and three lateralgroups of stabilizing ligaments. The talus articulates in a hingefashion with both the tibia and the fibula. The distal tibia and fibulaare stabilized by the tibiofibular ligaments (anterior and posterior),also known as the syndesmosis. The thick deltoid ligament supports themedial aspect of the ankle and helps limit eversion. The medial ankle isthe site of fewer injuries in the ankle since it is inherently morestable than the lateral ankle. Most ankle sprains are inversion injuriesinvolving either complete or partial tearing of the lateral ligamentcomplex. This complex is composed of three distinct ligaments: theanterior talofibular (ATFL), the calcaneofibular (CFL), and theposterior talofibular (PTFL) which are typically injured in a sequentialfashion from anterior to posterior, depending on the severity of theinversion.

Studies have shown that rapid lateral body movement actually accountsfor relatively few inversion sprains and further that most ankle sprainsoccur when landing from a jump, with the foot in an inverted,plantar-flexed position. Several studies support the theory that anklesprains frequently involve disruption in ankle proprioception thatprevents the ankle from protecting itself. Eversion ankle sprains,however, have been found to be the result of outside forces (such ascontact with another player), rather than the result of inadequateproprioception.

The present invention provides an ankle brace as an alternative to ankletaping. The braces of the prior art have been used instead oftraditional taping by many athletes at all levels of competition andoffer several advantages: for example, braces are reusable,re-adjustable and can be self-applied. There are estimates thatprofessionally applied taping can run in the tens of thousands ofdollars for a professional athlete for a full season of play. Ankletaping is estimated at approximately three times more expensive thanbracing over the course of a competitive season.

However, the prior art bracing has disadvantages including the fact thatmany athletes feel less comfortable or stable when wearing braces thanthey do when the ankle is taped. Braces also can become worn out, ortorn and require frequent replacement, for example, many brace designsuse hook and loop fasteners or Velcro™, which has a tendency to relax orslip during use. They also can be considered to be cumbersome orintrusive to the range of motion, and proprioception necessary tocompete in some sports. In addition, many athletes prefer the feeling ofcontrol that taping presents, although it has been shown that taping canlose its supportive effect after a short period of active use.

Many studies have compared taping versus bracing of the ankle but it isdifficult to control the many variables associated with ankle injuries(including for example, playing surface, shoe wear, individual inherentstability, and intensity of competition on both a team and individuallevel). Most of these studies have shown that the prior art braces areslightly more effective than taping and that both are better than nosupport, and further that external ankle stabilization does decreaseinversion sprains. The mechanism for this protection is not fullyunderstood. While it would appear that external devices would increasethe structural stability of the ankle and make the ankle lesssusceptible to inversion, studies have shown that there may beadditional factors that lead to the beneficial result. It has beendetermined in one study, for example, that taped participants hadimproved proprioception both before and after exercise compared withuntapped controls. The authors of that study postulated that thetraction and/or pressure imparted to the skin of the foot and ankle viataping or bracing provided improved sensory input and thus improvedproprioception, resulting in fewer ankle sprains. Another study comparedthe neuromuscular properties of taped versus un-taped ankles so as totheorize on a measure termed the proprioceptive amplification ratio(PAR), which incorporates neuromuscular properties such asproprioception and degree of mechanical stress. That study found thattaping did provide increased ankle protection.

While some concern has been expressed that prolonged taping or bracingof the ankle may result in weakened ankles that are more prone toinjury, at least one study has shown that consistent ankle brace use didnot change the latency to inversion of the peroneus longus (an importantstabilizer of the ankle, particularly against inversion, the most commontype of ankle injury).

The present invention provides an answer to the issues of injury relatedand prophylactic ankle support in the form of an elastomeric ankle bracethat provides for directed and anatomically configured support, as wellas proprioceptive reinforcement for the brace user. The brace of thepresent invention provides an increased PAR as compared to the prior artbracing which is a result of the support framework providing stoplimited vector directed support in addition to or combination withsurface achieved tactile response.

SUMMARY OF THE INVENTION

The brace is in the form of a sleeve (which can be considered a singleunit that spans the joint or a first part on one side of the joint, anda second part on the second side of the joint) and formed from anelastic material in which a more distal portion comprises a loop, whichis preferably a continuous loop, which encircles a portion on one sideof the joint or joint complex and a more proximal portion that encirclesthe other side of the joint or joint complex. The brace further includesnegative or void areas (i.e. “fenestrations”), such as weakened areas,recesses or apertures that act to re-direct forces through thecomplementary areas which assume the stresses in response to theexistence of the negative area. In further embodiments the sleeve alsoincludes a web or framework of stiffer, more rigid, or less elasticsupport members that interconnect with each other and between a proximaland distal anchor, each of which encircle the limb. This web orframework acts to augment the natural ligaments. In a way that providessupport but which limits potentially harmful motion.

The ankle brace which illustrates the present invention includes thefoot portion and the leg portion which join together at the ankle joint,and is comprised of an interrupted web (in this case meaning a flat, andpotentially homogeneous cast or molded sheet) of elastomeric material inwhich the interruptions or openings together with the materialcharacteristics of the elastomer define the manner in which the bracefunctions. In particular, the material forming the foot portion and theleg portion are separated by the heel opening and the TFT opening whichallow the foot portion and the heel portion to form a joint therebetween, and to accommodate movement at the ankle joint withoutunnecessary material or bunching. This is a particular advantage for asoft brace that is worn underneath a shoe, other athletic footwear, or ashin guard.

In addition, the combination of the malleoli openings and the twoopenings at the medial and lateral surfaces of the plantar covering ofthe foot portion of the brace act so as to provide direction as toresistance of force sustained within the web of material that is definedby the combination of the openings. Thus, the brace of the currentinvention is designed to allow as much safe freedom of movement to thewearer as possible, but to provide resistance to movement that could beharmful. In particular, the device is intended to inhibit inversion inplantar flexion (and to help stabilize the syndesmotic ligament) so asto avoid “rolling” an ankle. The brace is intended to provide externalsupport tantamount to external ligaments and or fascia, that reinforcesin proper places but which relieves pressure where it is needed. Thus,the device acts in tension and compression to buttress the syndesmoticligament at the top, and in the cross-configuration to buttress the ATFL(anterior tibiofibular ligament), and the CFL (calcaneal fibularligament), with a medial web member that buttresses the deltoidligament. In addition, the elastomeric nature of the brace material,coupled with the form can act to provide energy re-balance to thewearer, where the kinetic energy is re-circulated or re-coiled to theuser, while inhibiting potentially dangerous forces applied to the jointcomplex. The material also provides proprioceptive feed-back to the userand the elasticity and/or stickiness of the material helps to remind theuser to maintain tone. It is preferable that the material is “alive” orslightly sticky to the skin of the wearer. A desirable level ofstickiness would be the feel of slightly under-cured natural latex, or amaterial that has been exposed and allowed to dry to a solution ofsugar-water, or something less adhesive than a traditional band-aid or alight masking tape. Acceptable values measured according to ASTM,D3330D/D3330M, Test Method F at 90°, for peel adhesion of pressuresensitive tape, would be 0.0005-50 N/100 mm, preferable 0.5-30 N/100 mm,and most preferably 0.2-25 N/100 mm.

In a further embodiment of the invention, additional, and optionallyexternal adjustable struts are provided to provide joint stabilityagainst typical directions of ligament strain. Specifically, as relatesto the brace of the present invention in use for ankle support, thestruts are provided as two additional add-on elastomeric strap membersthat extend diagonally across the lateral malleoli to provide lines ofsupport in two more or less orthogonal directions extending inferiorlyto superiorly and posteriorly to anteriorly respectively. Since thesestraps can be added to the brace to supplement the brace itself, theycan be provided with more or less stretch to provide for more or lesssupport to the joint. Advantageously, the straps have easy attachmentmeans, such as the illustrated puck and grommet mechanism, in which thestraps include spaced apart pucks that can be pushed into a retainedrelationship with the grommet, and that can be popped out of engagementby pulling outward on the extensions.

In an adjustable version, the brace is in the form of a sleeve (whichcan be considered a single unit) that spans the joint or a first part onone side of the joint which comprises a flat web or band of materialthat is wrapped around a body on one side of the joint and is closed byclosure means which provide for adjustability and for the ability toprovide directed tensioning. The sleeve also includes a second part onthe second side of the joint and formed from a continuous (i.e.integral) elastic material where a more distal portion comprises a loop,which is preferably a continuous loop (and here it is envisioned thatthis loop could also be formed by closing a flat web to form a circle),which encircles a portion on one side of the joint or joint complex anda more proximal portion that encircles the other side of the joint orjoint complex.

The leg portion of the brace includes a proximal opening that encirclesthe lower leg sufficiently above the lateral and medial malleoli inorder to provide a suitable proximal anchor on the leg of the user. Asecond distal anchor is joined at the foot opening. This portion of thebrace also forms a continuous loop, but advantageously is openable, forexample, to the rear, or preferably slightly lateral to the Achillestendon, for entry into the brace, and also to provide adjustability inthis portion of the brace. In a further embodiment, the first and secondanchors are stiffer more rigid elements, formed for example, of a higherdurometer material, (e.g. 85+/−30 and preferably 70+/−10, and mostpreferable 70+/−5 durometer on the Shore A scale.) The anchors areinterconnected by supports or struts in the form of strips, or bandswhich have a much longer length than width (I.e., more than 5×, andpreferably more than 10× but where the width is between ⅛ to ½ inch andthe lengths are from ½ to 15 inches depending on whether the length istaken for a single segment, which may be as short as ½ inch or as longas 10 inches extending along a line, or for an aggregate of a number ofsegments) of the same or similar material, The supports interconnect toform a framework or network of ligament complementary support which aidsthe joint and inhibits “harmful” motion while freely permittingacceptable motion.

Various closure mechanisms can be used at the anchor juncture(s),including straps, bands, webs, and cables having a closure means thatmates with a corresponding closure means on the lateral side of thesleeve. These closure means could include buttons, hooks, latches,ratchet mechanisms, post and pin, groove and slide, hook and loop, postand loop, Velcro, cables, and zippers to name a few. The presentinvention also provides novel mechanisms for closure of a soft and/orelastomeric brace.

The brace further includes negative or void areas, such as weakenedareas), recesses or apertures that act to re-direct forces through thecomplementary areas which assume the stresses in response to theexistence of the negative area. The weakened areas can comprisecomplimentary webs of softer, more yielding, lower durometer material,e.g. having a durometer of 35+/−10, and preferably 40+/−5, on the ShoreA scale. This material may also include perforations, such as pores orholes of 0.0001-0.05 inch diameter, to allow for the evaporation ofperspiration. These pores may also affect the softness of the material.

In further embodiments, the distal and proximal anchors are connectedstructurally by struts or supports which are different than (but whichmay be integral to, as by thicker and thinner areas) the basic sleevewebbing (i.e., by bands, straps, laces, or cables which are less elasticthan the remainder of the brace,) so as to transmit forces directlybetween them and between the distal and proximal anchors by means ofsupports which can permit desired motion which is deemed to be within ahealthy range of motion, but restrain undesired motion, which would bepotentially harmful to a vulnerable joint. The higher stiffness (orlower elasticity or resistance to stretch) can be effected by a numberof methods, including a change in material, a change in materialcharacteristics, including cross-linking or durometer which can becaused by the manufacturing method or by the ingredients, or a change inthe geometry, including thicker or wider or higher volume of material soas to direct, inhibit or manipulate forces transmitted to the affectedjoint during use. Preferably these supports extend radially from themalleoli supports much like a hub includes spokes in a spoke wheel, andthe supports are linked to a peripheral support system which includesthe proximal band, the rear band, the plantar supports, the distal band(which may include a v-feature to accommodate various foot widths andshapes) and an anterior support which may be offset from the medialplane in order to provide for a more comfortable fit.

Finally, the brace can include pockets for sensors including motion ofpressure sensors, including for example, transducers or accelerometers,that can be used for kinetic assessment such as standard gait analysis,or athletic training. Alternatively, these sensors can be integrated orembedded into the brace.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front side lateral view of the right ankle brace inaccordance with the present invention shown on the ankle of a user;

FIG. 2 is a front side view of the medial side of the ankle brace ofFIG. 1 ;

FIG. 3 is a side view of the medial side of the ankle brace of FIG. 1 ;

FIG. 4 is a side view of the lateral side of the ankle brace of FIG. 1 ;

FIG. 5 is a lateral side view looking up from the bottom of the footportion of the ankle brace of FIG. 1 ;

FIG. 6 is a medial side view looking up from the bottom of the footportion of the ankle brace of FIG. 1 ;

FIG. 7 is a top view of the ankle brace of FIG. 1 ;

FIG. 8 is a front looking back of the ankle brace of FIG. 1 ; and

FIG. 9 is a bottom view of the ankle brace of FIG. 1 .

DETAILED DESCRIPTION OF THE INVENTION

In the ankle brace 10 that is shown, a more distal portion 12 encirclesthe mid-foot of the user 14. The brace is provided in a right versionand a left version which are mirror images of each other, and also canbe provided in multiple sizes, including for example small and large, orpediatric, ladies and men. The brace is illustrated as a right anklebrace and the left ankle brace is a mirror image of the right anklebrace shown.

The brace includes a web 22 of flat elastomeric compound or material,which, if opened, would form a flat sheet of relatively uniform oruniform thickness and comprised of a homogenous composition, whichoptionally includes reinforcing material such as fiber, but which ispreferably not a mesh, woven or non-woven fabric in this configuration.The web can form a sleeve 23 comprising the web members of the footportion and the leg portion, and which underlays the interlinkingnetwork of relatively more rigid (i.e. compared to the sleeve material)bands of elastomeric support. The foot portion 12 has a distal opening16 that is configured to snugly surround the user's foot, atapproximately the neck of the fifth metatarsal through the plantarsurface to the middle of the first metatarsal and arching proximallytoward the tibial fibular talar joint over the dorsal surface of thefoot. At the other end, the foot portion 12 ends on the plantar sideposterior to the end of the medial arch in a heel opening 18 suitable toexpose the fat pad of the heel (approximately ½ of the way posteriortoward the heel end of the calcaneus) on the posterior side, and belowthe insertion of the gastrocnemius into the Achilles tendon as itextends upward on the leg to form the bottom boundary of the leg portionof the brace. The foot portion 12 ends on the anterior side of the ankleat the “eye of the ankle”, i.e. on the superficial aspect of theanterior ankle at the joint of the tibia/fibula/talus (or the “TFT”joint). The foot portion 12 includes a web of material 22 (preferablymolded or cast) that covers an area corresponding to the cuneiforms andthe cuboid bone and the navicular bone. On the medial and lateral sidesof the brace, the foot portion runs diagonally between the anterior andposterior openings where it joins the leg portion 30 which surrounds thebottom portion of the leg or the vertical portion of the ankleapproximately ⅓ of the way up the lower leg, and below the bellies ofthe distal aspect of the gastrocnemius.

The leg portion 30 of the brace includes a proximal opening 32 thatencircles the lower leg sufficiently above the lateral and medialmalleoli in order to provide a suitable anchor on the leg of the userfor the forces applied by and to the brace. This portion of the bracealso forms a continuous loop when it is closed.

In addition to the previously described openings including the twoterminal openings there are several other functional negative areas or“fenestrations” (used herein to mean areas of decreased resistance,including for example through openings, as well as areas in which thereare material changes, such as a more stretchy or less cross-linked oreven a thinner web of material) in the brace. The two terminal openingsinclude the first or distal most 16, having a edge that runs across themid-foot on the plantar side, and arching back toward the TFT joint overthe top of the foot to the proximal aspect of the metatarsals; and thesecond or proximal most opening 32 forming a roughly circular openingwhich encircles the lower leg about 1.5-3.5, and preferably 2-2.5 inchesabove the malleoli or a third of the way up the lower leg and below thebelly of the gastrocnemius.

The functional openings include the opening at the heel 18, which isopen to or excludes coverage of a significant portion (i.e. 75% or moreor all of) of the surface area of the heel pad, having an edge just infront of the medial process of the calcaneal tuberosity, and on the legportion of the brace just above the insertion of the Achilles Tendonsuperior to the calcaneal tuberosity. Further, the brace includes twoopenings that correspond 1) to the medial malleolus 40 and 2) to thelateral malleoli 42. In the present embodiment, on the medial side, themalleoli openings 40, 42 are roughly circular or oval in shape boundedby support bands as are further described below. These openingsapproximate a size slightly larger than an average size of a malleolus.The opening ends proximally in front of the tuberosity of the fifthmetatarsal, and distally roughly 0.5-1 inch behind the terminal openingof the foot portion at the neck of the fifth metatarsal.

The brace includes the foot portion 12 and the leg portion 30 whichseamlessly join together at the ankle joint to form one integratedsurface, and is comprised of a web of elastomeric material having aninterlinking network 15 of support bands or struts in which thecombination of the web, the network of bands of external supportstogether with the material characteristics of the material define themanner in which the brace functions. In particular, the sleeves formingthe foot portion 12 and the leg portion 30 are separated by the heelopening 18 and the network of support bands 15 include a pair of openmalleoli supports 40, 42 including radially extending struts 44 whichallow the foot portion and the heel portion to form a joint 50 therebetween, and to accommodate movement at the ankle joint withoutunnecessary material or bunching. This is a particular advantage for asoft brace that is worn underneath a shoe, other athletic footwear, or ashin guard. In addition, the combination of the malleoli supports 40, 42and the two openings at the medial and lateral surfaces formed betweenthe medial and lateral support network and of the plantar covering 52 ofthe foot portion of the brace act so as to provide direction as toresistance of force sustained within the web of material that is definedby the combination of the openings. Thus, the brace of the currentinvention is designed to allow as much safe freedom of movement to thewearer as possible, but to provide resistance to movement that could beharmful. In particular, the device is intended to inhibit inversion inplantar flexion (and to help stabilize the syndesmotic ligament) so asto avoid “rolling” an ankle. The brace is intended to provide externalsupport tantamount to external ligaments and or fascia, that reinforcesin proper places but which relieves pressure where it is needed. Thus,the device acts in tension and compression to buttress the syndesmoticligament at the top, and in the cross-configuration to buttress the ATFL(anterior tibiofibular ligament), and the CFL (calcaneal fibularligament), with a medial web member that buttresses the deltoidligament. In addition, the elastomeric nature of the brace material,coupled with the form can act to provide energy re-balance to thewearer, where the kinetic energy created in a muscular exertion of theuser is re-circulated or re-coiled to the user, while inhibitingpotentially dangerous forces applied to the joint complex. The “spring”that results, and the resilient contact of the brace with the surface ofthe ankle also provides a proprioceptive feel to the user that helps toprotect the ankle joint.

It is a further advantage in some instances to provide the brace withsupplemental tensioning means that can be adjusted to suit a particularuser. This embodiment is also illustrates a rear opening aspect of theinvention in which the leg portion has a opening 115 between the medialand lateral portions that preferably overlap or abut each other toencircle the leg, and from which straps 108 extends to allow forclosing, tightening or tensioning, and which also include closure means,in this illustrations hook and loop or Velcro fastening means 109. It isof advantage that the tensioning means act to inhibit stress to thesyndesmotic ligament, to the TFTL, and to the TCL. Thus, the tensioningmeans advantageously extend from the plantar supports covering (oroptional footplate) diagonally upward across the anterior hinge of theankle in the vicinity of the cuboid and navicular bones, and possiblyeven to a further tensioning member or anchor at the proximal end of thelower leg portion of the brace. These means can include straps, laces orcable members that are designed so as to provide for adjustable degreesof tensioning, as well as adjustable directions of tensioning to allowthe wearer to customize the feel and size. The device acts in tensionand compression to buttress the syndesmotic ligament at the top, and inthe cross-configuration to buttress the ATFL (anterior tibiofibularligament), and the CFL (calcaneal fibular ligament), with a medial webmember that buttresses the deltoid ligament.

The present invention is designed to provide some syndesmosis stabilityabove the malleoli. In a further adjustable embodiment, it illustratedwith a rear entry, i.e. open toward the posterior portion of the leg,but with an adjustable closure fixation point more anterior oranterolateral, (preferably not medial), with tension from posteromedialto lateral so as to pull the fibula anteriorly to help with syndesmosisstability and ankle. The optional superior band is comprised of areasonably high tensile strength to protect the syndesmosis. The braceis designed to provide a definite end to plantar flexion and inversionand also some level of protection on the syndesmosis.

It is envisioned that the brace comprises an interlinking network ofsupports 120 or elastomeric bands such as struts built into the lateraland medial side of the brace on the lateral side of the brace radiatingoutward from the medial 40 and lateral 42 malleolus supports andextending between the foot portion 12 and the superior portion of theleg support 30. On each of the lateral side and the medial side thesupports or struts 120 form a first portion 121 to support the foot anda second portion 122 to support the leg of the user. The first portionand the second portion are hinged at the ankle joint at an axis ofrotation that permits the ankle to hinge about the line 50. This hingeis formed by the provision of a medial hub at the medial malleolussupport 40 and the lateral malleolus support 42. The first portion isjoined to a distal band 125 that encircles the foot and a proximal band127 that encircles the leg. The network is connected to these anchorswhich act to support the struts in tension and to allow the interlinkingnetwork to actually support the ankle in movement, like the spokes of awire spoke wheel or a cable bridge. The struts comprise a series ofstruts which include at least one lower lateral strut 131 connecting themalleolus support 42 to the band 125 and a lateral posterior strut 135connecting the lateral malleolus support 42 to the extension of the heelband 133 defining the heel opening which in this case forms a closurestrap 137. The struts also include two superior lateral struts 139 whichconnect the lateral malleolus support 42 to the top band 132 which formthe top anchor for the leg portion of the brace. In addition, there aretwo anterior struts 131 which connect the lateral malleolus support 42to the distal foot band that forms the foot anchor 134. Preferably,these two anterior struts form a gusset 140 or v-shaped link to the footband 134, which is disconnected between them distally so as to allow thefoot band to have a degree of give to accommodate various foot shapesand to allow the brace to be put on.

On the medial side, there is a corresponding first foot portion ofinterlinking bands and a second leg portion of interlinking bands orstruts which connect the medial malleolus support (i.e. a ring which iscircular or preferably oval to encourage hinging that surrounds themalleolus). The medial struts include a pair of anterior supports 152that join the malleolus support 42 to the foot anchor 125 and a pair ofsuperior struts 154 that join the malleolus support 42 to the proximalband 127 which forms the leg anchor for the interlinking network ofbands. At the rearward portion of the interlinking network, the medialstruts join directly into the medial heel band member 136 which joinswith the proximal anchor and extends into the medial strap which closesthe brace at the top of the brace. The lateral strap and the medialstrap include closure means 109, such as hook and loop that join with amating closure means 109 on the leg portion of the brace. The brace isdesigned so that the hook and loop avoid tension in the line offastening. Thus, the hook and loop can be used to size and tension thebrace, but resist the problems often encountered with this type offastening means, such as loosening, opening or wear.

These struts 120 should have a definite endpoint at say 90-110% ofphysiological plantar flexion/inversion before easing to a firm stop atwhich point there is recoil. The basic sleeve of the brace is intendedto be very tight on the user with a low tensile strength and durometerso that it molds well to the ankle. The struts have a high tensilestrength that eases to a firm end-point before recoiling. This isadvantageously accomplished by providing elements (for example such asone or more fibers, cable or bands that are optionally sinusoidallyplaced) that have a high resistance to stretch embedded within orcarried on the elastomeric sleeve member. This brace acts in tensionrather as a buttress as in the prior art.

In addition, tensioning or closure mechanisms permit the wearer to pullthrough them and get a feel of tension, which provides a reassuring feelto the wearer. This tension is set such that it could result in a veryhigh tensile strength at the end of range of range so that it can bereally quite stiff within a range that is totally safe for the user.Optional closure mechanisms include various mechanisms, such as Velcro,watch strap level backs closure, hook and eye, pin and post, buttons,zippers, cables, laces to name a few. One advantageous closure is awatch strap type closure with a pulley at sinus tarsi level to retainthe tensioning bands in an anatomical position, and having tensioningposts protected with a hinged door on a button at the fibula for extrasecurity. Also, the tensioning mechanism can include a winding mechanismthat translates the rotation of a tensioning dial member to thetensioning strap in order to increase the tension provided by thetensioning strap.

The leg portion 30 of the brace includes a proximal opening 32 thatencircles the lower leg sufficiently above the lateral and medialmalleoli in order to provide a suitable anchor on the leg of the user.This portion of the brace is open to from a planar web 33 (i.e. a flatband) that can be closed to form a continuous loop about the lower leg.The web 33 includes one or more extension 35 that can be a strap or bandof varying thickness and which is of a length preferably so that the legportion 30 fully encircles the lower leg and that the strap, band orcable 35 that extends from a first side of the web 33 can be pulled to adesired tension and secured by means of closure means 109 on the strapor medial side to mating closure means on the lateral side of the web33. The embodiment shown includes an upper strap 35 on the medial sideand a lower strap 37 on the lateral side which spirals upward about theleg portion of the brace. Various closure mechanisms can be used at thisjuncture, including straps, bands, webs, and cables having a closuremeans that mates with a corresponding closure means on the lateral sideof the sleeve.

The superior band 35 is integral with the top (i.e., the superior edge)of the leg portion 30 of the brace and at least in part, defines thesize and shape of the proximal opening 32 that encircles the lower leg.The superior band 35 includes a closure mechanism that mates with amember on the band or on the brace body or on an attachment or strap onthe brace to allow the closure of the brace, as well as sizing andtensioning as is desirable. The brace also includes a posterior band 37which closes the rear of the leg portion 30 closer to the ground andwhich can overlap from the medial to lateral side as shown or from thelateral to medial side. The posterior band 37 also includes a closuremechanism, which cooperates with a mating member on the brace.

The brace is shown with a series of plantar supports 150, which connectthe heel band and the distal foot band that forms the front anchor.Alternatively, these supports may instead be comprised of a plantar footplate.

Preferably when closed the rear opening of the brace 108 starts at 6:00o'clock and extends laterally. This avoids the overlap occurringdirectly posterior to the Achilles tendon, which could cause aggravationwith running, jumping or use of the ankle joint over time. The medialflap of the leg portion is pulled counterclockwise toward the lateralflap which tends to thin the material our slightly (depending on thePoisson's ratio) and resulting in less thickness and a lower profile.Optimally the overlap in the sulcus with the lateral flap is at about4:30-5:00 o'clock (relative to the anterior medial line). The lateralflap is thinned down near the slit to 1.5−2+/−0.5 mm in thickness. Thestrap and material are designed so that a short distance pull creates arelatively large amount of stress. The placement of the mating lateralclosure members is thus dictated on the configuration and materialchoices so that multiple locations close together results in a wideselection of resulting tensions and sizes, and allowing the user asignificant range of tension within a small range of pull.

The pulling takes the posterior flap to 5:00 o'clock post tensioning.This allows about 90° of workable circumference for placement of thelateral closure means. Preferably, the closure means are low profile andwill not aggravate the user. The bands coming off the medial flap can berelatively short and thus result in good tensioning reproducibility andalso for a significant amount of tensioning with a relatively stiffelastomer. Preferably the bands originate from a hard polymer, which isembedded into the end of the sleeve to provide increased durability anda more even pull. The bands can taper in height, taller at the origin,and thinner at the insertion (i.e. the location of the male closure) tofurther distribute the stress. There is optionally a pull connected tothe male closure member, such as a stiff polymer or cloth which acts asa handle for the user during assembly and which will lay flat when theclosure means is assembled.

Also the brace may be provided as an adjustable brace with a rear entryand closure means that allow sizing of the open portion. For example, itis advantageous to provide an open loop for the leg portion which can betailored to a desired size, and which can even be re tailored at a laterpoint. The anatomic location of the closure mechanism is important, andideally, this is at the posterolateral aspect of the ankle joint; housedbetween the Achilles and distal fibula. This minimizes the interferencewith many athletes' function as well as minimizes general interferenceincurred during gait, again, depending on the mechanism of choice.Alternatively, the closure mechanism can be located on the medial sidewith the tensioning means (or straps) pulling in the direction of thestruts laterally. Advantageously, the tensioning means provides for ½ to1 centimeters of adjustability, (in particular if the brace is providedin three sizes), depending on the material of the tensioning means andthe size range for which the brace is intended.

In addition, in a further embodiment, the brace is illustrated asincluding a framework of a stiffer (i.e. higher durometer material ofapproximately 95 durometer+/−15, preferably +/−10 and most preferably+/−5 on the Shore A scale. This framework 300 includes a proximalanchor, which encircles the upper leg and in this case includes a strapwhich engages a closure mechanism on the front of the brace. Theproximal anchor is a band and forms a flat continuous (i.e. looping backon itself) ring 35 of relatively narrow width and constant thickness andwhich circles the foot. Advantageously, the ring also includes at leastone, but optionally more, (i.e. two three, four or more), v-shaped (orother shape which include a wider opening and a tapering portion whichresists but will allow for expansion of the circumference of the ring)gusset which allows the proximal anchor to expand without losing itsfunction as an anchor in order to allow for size variations of thewearer. The framework also includes an opening 42, 40 on each of thelateral and the medial sides, preferably oval as previously described,to accommodate the malleoli. Struts extend from the proximal anchor tothe malleoli openings. Further struts extend upward from the malleoliopenings to the proximal anchor to complete the circuit between thedistal anchor and the proximal anchor. This brace also includes a lowerstrap 37, which wraps the ankle at a lower position and from the lateralto the medial side and fasten at a hook and loop (i.e. Velcro) on thefront of the brace 109. This area is stiffer and helps to support theanterior portion of the brace framework. The framework front supportforms a base for the leg portion of the closure mechanism, and a rearmember 136 frames the heel opening and is linked to the rest of thebrace through links to the malleoli openings. The fenestrations in thiscase, are actually areas of integrated softer material, for examplehaving a durometer of 35+/−10, and preferably +/−5 on the Shore A scale.This material is a relatively soft sheet of elastomeric material, with auniform thickness from surface to surface, which is slightly sticky tothe touch, as can be formed by injection molding or by casting at alower cross-linking. This softer portion of the sleeve can also includeperforations to allow for perspiration, or can include texturing to thesurface for proprioceptive reasons. The web portion at the gusset may beadvantageously strengthened, for example by eliminating the perforationsin the remainder of the web in order to provide for greater strengthhere since the front of the network is open from the network to providefor greater fit.

The brace is made, for example by molding such as injection or transfermolding, liquid silicone molding or reaction in mold casting, abio-compatible elastomer from a material of suitable durometer toprovide the desired fit, and elastomeric characteristics. The bracepreferably is made of a material that exhibits equal stretch in at leasttwo dimensions (i.e. the X, Y directions). This material can be mademore resistant to provide further support, for example of thesyndesmotic ligament, by various means, including the additional ofsupports or struts which might be provided by an integral (samematerial) thickening of the brace in a defined area, or by changes inthe material itself, such as higher rate of cure or cross-linking or theaddition of other materials such as reinforcing fibers or the use of asecond elastomeric material having greater resistance to an appliedforce, like a higher durometer or Young's modulus or modulus ofelasticity, and which could be embedded in the brace, co-molded, oradhered to the inside or outside of the brace. The brace is designed toallow motion with a limited end-point; to encourage the recoil of energyand to allow for the potential prevention of harmful forces, i.e. thebrace permits motion that is safe within a defined range, but inhibitsabnormal or dangerous motion.

The brace forms a two part sleeve which is in substantial contact withthe skin of the user between the two terminal ends of the brace. Thus,in the first embodiments, while there are fenestrations or openings inthe brace, the remaining web occupies at least 40%, and preferably atleast 50%, and even more preferably at least 60% or 75% of the areadefined by the outline of the brace. In the embodiments having a morerigid framework and fenestrations with a softer web of material theseratios are reversed. The inferior surface may advantageously include amesh, surface treatment or textured finish to increase the breathabilityand to prevent slippage.

In addition, the material is intended for a particular tactileexperience at the surface of the skin of the wearer so as to provide aproprioceptive reminder to the wearer of the type that has been found tohelp inhibit ankle sprains. It is preferable that the brace has aslightly tacky feel at the skin interface. Thus, the brace providesbio-feedback to alert the stabilized joint so that it acts to inhibitundesired motion within that joint. In further embodiments, the bracemay be put on wet, or over an inner sleeve that helps to enhance thetactile experience, such as including a roughly textured surface havinga pattern of bumps, ridges, dimples, cross-hatching or protrusions.

The brace of the present invention can be used in a variety of joints.While the present invention can be used for hinged joints it ispreferably for use in joint complexes, so that for example the “ankle”brace actually is intended to stabilize the ankle, subtalar andtalonavicular joints, and the concepts set forth herein can be useful insupport of other joints, including for example those located at thewrist, the elbow, the shoulder, the knee, and the fingers.

The present invention also has application for treatment of plantarfasciitis, medial and lateral (elbow) epicondylitis, toe andfinger/thumb synovitis. A particular advantage of the present inventionis that the brace is designed to “stretch” up to a defined endpoint andthat an effective “stop” is reached by a tensioning member that actslike an elastomeric “ligament” placement. This can be provided by achange in structure of the brace, such as increased volume of materialdesigned to limit the stretch, a different material characteristics,such as a higher degree of cross-linking, or change in materialincluding for example, a cohered portion along a lateral edge, or anadhered portion along a top or bottom surface (including fabric whichcould be woven, and which could serve additional purposes, such as skininterface, bacterial or fungal control or odor control), or embeddedmaterials, such as fibers or wires which exhibit relatively littlestretch and are configured to provide a limit to a range of stretch at agiven stop point.

The invention relates generally to a molded elastomeric sleeve of abiocompatible material having a defined hardness and elasticity, shapeand configuration in three dimensions (adapted to the anatomy of ahypothetical user). For the ankle this means a brace configured to endon the foot at the neck of the fifth metatarsal and on the lower legbelow the belly of the gastrocnemius, and having an opening at the heelcup and at the eye of the ankle joint, at the medial and lateralmalleoli, and at the navicular bone and optionally including additionalsupport of additional material or a stronger or less elastomericmaterial on the lateral side which resists a force applied to the anklein inversion, including, for example, an integral support or attachmentsuch as a tension strap positioned anterolaterally to simulate thedirection of the ATFL for more anterolateral stability where there is asupport for syndesmotic stability, and one for ankle stability.

The basic sleeve of the brace is intended to be very tight on the userwith a low tensile strength and durometer so that it molds well to theankle. The material of the brace is ideally an elastomer, including forexample, a thermoplastic elastomer having a Shore A hardness of 2-50 at10 sec when measured in accordance with ASTM D2240, and a tensile breakat stretch of 2-6 MPa at 23° C. using Die C2 hour when measured inaccordance with ASTM D412, tensile stress of 0.08 to 0.8 MPa at strain100% and 0.2 to 1.5 MPa at 300% at 23° C. using Die C2 hour whenmeasured in accordance with ASTM D412, and an Elongation at break of800-1200% at 23° C. using Die C2 hour when measured in accordance withASTM D414, a tear strength of 7.5-20 kN/m when measured in accordancewith ASTM D624, and a compression set of 5-30% at 23° C. and at Time79200 sec when measured in accordance with ASTM D395. Thermoplasticelastomers are suitable materials, with material sold under thetrademarks Versaflex CL30, and CL2000X from PolyOne being preferablematerials, alone, or compounded with additional materials, such as othercross-linking agents, additional elastomers to achieve materialcharacteristics, reinforcing fibers and fillers, antimicrobial agents,colorants, and fragrances.

The brace in accordance with the invention includes struts laminated oradhered to the outer or inner surface or embedded within the sleevemember, and which have a high tensile strength that eases to a firmend-point before recoiling. This is advantageously accomplished byproviding elements (for example such as one or more fibers, cable orbands that are optionally sinusoidally placed) that have a highresistance to stretch embedded within or carried on the elastomericsleeve member. This brace acts in tension rather as a buttress as in theprior art. The brace could further include a fabric backing over anentire surface or over portions of surface in order to control thedirections of resistance including a weave such as a bias weave fabric,which limits the stretch to one axis and inhibits the stretch along theother two axes.

The through thickness of the sleeve will depend on the material andelasticity but is preferably “low profile” meaning that it can be worn,optionally with socks, under a user's pre-owned shoe, meaning that itdoes not require a different size than is worn without the brace.Preferably the thickness would be form 2-to-10 mm, with about 5-8 mm onthe lateral side and such that the brace still fits into the shoe and iscutout to go around the bony eminences. The medial side does not requirethe same resistance and could be 3-4 mm.

As designed, the brace optionally includes a self-formed (meaning thatthe foot plate is only loosely defined by an area of increased thicknessor hardness, and that the wearer's foot acts to define the shape of thefootplate in use) foot plate which contours around the heel moredistally around the base of the fifth, so as to improve ST(sustentaculum/talar) joint stability. Alternatively, the footplatecould be integral with the remainder of the brace, but could be moredefinitely defined, for example, by formation of a different, andpotentially stiffer, or harder material. Thus, the foot plate couldoptionally be provided in a different material, for example a harder, orless stretchy material or this could be accomplished using a differentconfiguration. Also, the footplate could optionally be thicker (i.e., by0.5-2 mm on the lateral side for approximately the length of the footplate or at least 50% of the length and approximately ⅕ to ⅓ of thewidth to bias the foot to the outside and in order to promote controlthe tension on the syndesmotic ligament.

The brace is intended to last at least one season of intermediate levelof non-professional use (i.e. 2-3 times per week), which is based onusage on the idea that the running shoes need to be changed every 300 orso miles, which is approximately 7-8 miles per week in a 9 month soccerseason, or alternatively for one month of heavy use, and wherein thelimiting factors include the continued support and configurationintegrity, odor-free characteristics, and stickiness or tack to providefor the proprioceptive reinforcement.

The invention relates to an ankle brace for a hypothetical user having aleg including an ankle joint complex extending from below agastrocnemius at the proximal side to behind the neck of a fifthmetatarsal on the distal side, the brace comprising a sleeve formed froma sheet of biocompatible elastomeric material having a through thicknessof from 1 to 7 mm, and the brace has a first portion which is a webformed from the sheet of the biocompatible elastomeric material whichforms a first continuous loop about a first axis and a second portionwhich is a web formed from the sheet of the biocompatible elastomericmaterial that forms a second continuous loop about a second axis; andthe first portion of the web having a proximal end which includes a topopening sized to fit below the belly of the gastrocnemius of thehypothetical user and the distal end of the first portion beingconnected to the proximal end of the second portion at a conjunction ofthe first portion and the second portion, and the distal portion of thesecond portion including a bottom opening sized to fit posterior to theneck of the fifth metatarsal of the hypothetical user; and the webincluding at least a first fenestration at the conjunction of the firstand the second portions which is configured such that the first axis andthe second axis are not the same.

It also relates to the previously described ankle brace as set forthabove wherein the fenestration is a through hole and wherein thefenestration is an area of decreased resistance in the web and whereinthe first portion of the web includes at least one opening for thelateral malleolus and wherein the first portion of the web includes atleast one opening for the medial malleolus.

The invention relates to the previously described ankle brace whereinthe elastomeric material is a thermoplastic elastomer having a Shore Ahardness of 5-95 at 10 sec when measured in accordance with ASTM D2240or a tensile break at stretch of 2-6 MPa at 23° C. using Die C2 hourwhen measured in accordance with ASTM D412 or a tensile stress of 0.08to 0.8 MPa at strain 100% and 0.2 to 1.5 MPa at 300% at 23° C. using DieC2 hour when measured in accordance with ASTM D412 or an Elongation atbreak of 800-1200% at 23° C. using Die C2 hour when measured inaccordance with ASTM D414 or a tear strength of 7.5-20 kN/m whenmeasured in accordance with ASTM D624 or a compression set of 5-30% at23° C. and at Time 79200 sec when measured in accordance with ASTM D395where the elastomeric material could be a elastomeric material is athermoplastic elastomer sold under the trademarks Versaflex CL30, andCL2000X from PolyOne including such an elastomeric material compoundedwith an additional materials selected from the group comprising otherelastomers, cross-linking agents, reinforcing fibers and fillers,antimicrobial agents, colorants, and fragrances, and in particularwherein the reinforcing fiber is selected from glass, steel and carbonfiber. And this ankle brace could be formed by molding or casting.

The ankle brace also relates to an ankle brace for a hypothetical userhaving a leg including an ankle joint complex below a gastrocnemius atthe proximal side and behind the neck of a fifth metatarsal on thedistal side, the brace comprising a sleeve formed of a web ofbiocompatible elastomeric material having a through thickness of from 1to 7 mm, and a that has a first portion which forms a first continuousloop about a first axis and a second portion that forms a secondcontinuous loop about a second axis; and the first portion of the webhaving a proximal end which includes a top opening sized to fit belowthe belly of the gastrocnemius of the hypothetical user and the distalend of the first portion being connected to the proximal end of thesecond portion at a conjunction of the first portion and the secondportion, and the distal portion of the second portion including a bottomopening sized to fit posterior to the neck of the fifth metatarsal ofthe hypothetical user; and the web including at least a firstfenestration at the conjunction of the first and the second portions andthe ankle brace further comprising a removable support member whichprovides resistance to a force applied to the anterior tibiofibularligament.

While in accordance with the patent statutes the best mode and preferredembodiment have been set forth, the scope of the invention is notlimited thereto, but rather by the scope of the attached claims.

What is claimed is:
 1. A rear-entry ankle brace which supports the foot,ankle and leg of a user comprising: (a) an elastomeric componentconfigured to span an ankle joint of a wearer, comprising: (i) a distalend portion having an arched foot portion that is configured to extendover and cover the top and opposite sides of a mid-foot of a wearer,(ii) a proximal end portion having an arched leg portion that isconfigured to extend over and cover a front and sides of a lower portionof a leg of the wearer, and (iii) an intermediate portion that extendsbetween the arched foot portion and the arched leg portion and comprisesan arched ankle portion configured to extend over and cover a front andsides of an ankle joint of the wearer, (iv) wherein the distal endportion, the proximal end portion, and the intermediate portioncollectively define a passageway for receiving therein the mid-foot,lower leg portion, and ankle joint of the wearer, and (v) wherein theproximal end portion defines a leg opening that extends from a proximaledge of the proximal end portion along an entire length of the proximalend portion, the proximal edge of the proximal end portion defining atop of the elastomeric component of the brace, the leg opening enablingthe proximal end portion to be positioned directly onto and cover thefront and sides of the lower leg portion of the wearer without passingthe mid-foot through the proximal end portion; and (b) two strapsattached to the proximal end portion for adjustably tensioning andsecuring the proximal end portion to the lower leg of the wearer; (c)wherein the elastomeric component further defines, on each of oppositelateral and medial sides of the brace, a central hub with band membersextending from the central hub and with interstitial areas extendingbetween the band members, the interstitial areas comprising areas thatare substantially thinner than the band members and that includeperforations extending through the elastomeric component forbreathability of the brace when worn; (d) wherein the band members havea thickness of from 1 to 10 mm and a Shore A hardness of 2 to 70 at 10sec when measured in accordance with ASTM D2240 so as to be capable ofbeing worn inside of a shoe; (e) wherein the arched foot portion of thedistal end portion comprises a distal band which forms at least 200degrees of an arc, and the arched leg portion of the proximal endportion comprises a proximal band; and (f) wherein the band memberscomprises a medial mid-foot band which extends from a first of thecentral hubs on the medial side to the distal band of the arched footportion to act as a first medial spoke, a lateral mid-foot band whichextends from a second of the central hubs that is on the lateral side tothe distal band of the arched foot portion to act as a first lateralspoke, a medial lower leg band which extends from the first central hubto the proximal band to act as a second medial spoke, and a laterallower leg band which extends from the second central hub to the proximalband to act as a second lateral spoke.
 2. A rear-entry ankle brace asset forth in claim 1, wherein the straps extend from the medial andlateral side of the brace and comprise one or more of hook and loopfastener, C-hooks, pin and post, zipper, tongue and groove, buttons,latch and hook, anchor and anchor receptacle, and laces.
 3. A rear-entryankle brace as set forth in claim 1, wherein the elastomeric componenthas a Shore A hardness of 2 to 50 at 10 sec when measured in accordancewith ASTM D2240.
 4. A rear-entry ankle brace as set forth in claim 3,wherein the elastomeric component has a tensile break at stretch of 2 to2 MPa at 23° C. using Die C2 hour when measured in accordance with ASTMD412.
 5. A rear-entry ankle brace as set forth in claim 3, wherein theelastomeric component comprises an elastomeric material having a tensilestress of 0.08 to 0.8 Mpa at strain 100% and 0.2 to 2.5 Mpa at 300% at23° C. using Die C2 hour when measured in accordance with ASTM D412. 6.A rear-entry ankle brace as set forth in claim 3, wherein theelastomeric component comprises an elastomeric material having anElongation at break of 500 to 1200% at 23° C. using Die C2 hour whenmeasured in accordance with ASTM D414.
 7. A rear-entry ankle brace asset forth in claim 3, wherein the elastomeric component comprises anelastomeric material having, a tear strength of 7.5 to 20 kN/m whenmeasured in accordance with ASTM D624.
 8. A rear-entry ankle brace asset forth in claim 3, wherein the elastomeric component comprises anelastomeric material having, and a compression set of 5 to 30% at 23° C.and at Time 79200 sec when measured in accordance with ASTM D395.
 9. Arear-entry ankle brace as set forth in claim 3, wherein the elastomericcomponent comprises an elastomeric material including one or more ofadditional elastomers, cross-linking agents, reinforcing fibers andfillers, antimicrobial agents, colorants, and fragrances.
 10. Arear-entry ankle brace as set forth in claim 9, wherein the reinforcingfiber is selected from glass, steel and carbon fiber.
 11. A rear-entryankle brace as set forth in claim 1, wherein the elastomeric componentis formed by molding or casting.
 12. A rear-entry ankle brace as setforth in claim 1, wherein the distal band forms a ring and includes agusset.
 13. A rear-entry ankle brace as set forth in claim 1, whereinthe brace further include a plantar foot plate that is stiffer than thebands of the elastomeric component.
 14. A rear-entry ankle brace as setforth in claim 1, wherein the brace includes a pocket for a sensor orfor support inserts.
 15. A rear-entry ankle brace as set forth in claim1, wherein the distal end portion comprises a soft flat elastomericplantar portion which forms a self-formed foot plate.